Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00225225 · ClinicalTrials.gov registry record · NA
Rosiglitazone-Induced Weight Gain
A NA study, sponsored by Stanford University.
- Terminated
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT00225225: Clinical Trial NA study, sponsored by Stanford University.
NCT00225225 is a NA study that was terminated before completion, run by Stanford University. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00225225, a NA study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study Summary
Given the high prevalence of type 2 diabetes and the 2- to 4-fold increased risk of fatal and non-fatal coronary heart disease events in these patients, long-term glycemic control is of great importance. TZDs improves glycemic control in patients with type 2 DM as well as enhances their insulin-mediated glucose disposal. However, the improvement of glycemic control seen with TZDs may be blunted in the long run by weight gain. Previous data on weight gain during TZD therapy in patients with type 2 DM is very sparse. It is generally assumed that an increase in adipocyte differentiation is the cause of weight gain in association with TZD treatment which may limit their use. Increased body weight assumed to compromise the positive effects of treatment. There is also a theoretical concern that, with the development of new adipocytes, future weight loss may be difficult. However, if weight gain is primarily due to failure to adjust caloric intake in proportion to the decrease in urinary glucose loss, it is totally preventable. It has been previously shown that improvement of glycemia favored weight gain by decreasing the energy loss in the urine as glucose. Severity of weight gain appears to be proportional to the level of glycemic control achieved. The overall goal of the proposed research is to provide the experimental evidence for the later alternative by showing that the modest weight gain that takes place in association with effective rosiglitazone treatment of hyperglycemic patients with type 2 DM is primarily due to its therapeutic efficacy. More specifically, by decreasing the caloric intake in proportion to a decrease in urinary glucose loss associated with improved glycemic control, we will be able to prevent significant weight gain following Rosiglitazone treatment. In order to provide an optimal dietary modification that can be universally applied to TZD-treated patients in clinical practice, we will have a group with a fixed amount of caloric restriction p
Interventions
- DRUG Rosiglitazone
- BEHAVIORAL dietary recommendation for weight maintenance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2002-10 |
| Est. Completion | 2005-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00225225
The ClinicalTrials.gov registry entry for NCT00225225 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rosiglitazone is the first listed.
NCT00225225 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00225225 about?
NCT00225225 is a clinical study titled "Rosiglitazone-Induced Weight Gain". Given the high prevalence of type 2 diabetes and the 2- to 4-fold increased risk of fatal and non-fatal coronary heart disease events in these patients, long-term glycemic control is of great importance. TZDs improves glycemic control in patients with type 2 DM as well as enhances their insulin-medi...
What is the current status of trial NCT00225225?
This trial is currently terminated. It is a NA study. The enrollment target is 45 participants. The study started on 2002-10. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00225225?
The interventions under investigation include: Rosiglitazone (DRUG), dietary recommendation for weight maintenance (BEHAVIORAL).
Who is sponsoring clinical trial NCT00225225?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.